Patent Application
20170044469
The present disclosure relates to medical device safety and, more particularly, to an apparatus and method for providing a visual indication that a sufficient amount of abrasive scrubbing has occurred for a given period of time to properly sterilize various medical devices and medical equipment including needless intravenous hub-and-port systems.
The development of needleless intravenous (“IV”) administrative systems began in the 1990s to protect against needle stick injuries, which proved dangerous due to the increased spread of blood-borne diseases. The IV systems also provided a means for connecting multiple medicines to a patient without additional needles, thus aiding healthcare professionals and easing patient discomfort.
Unfortunately, these IV systems lead to an estimated 250,000 IV device-related bloodstream infections (“BSIs”) each year in the United States. Each case has an attributable mortality rate of between 12 and 25 percent. It is estimated that these preventable infections make up 4% of medical malpractice claims on doctors and cause hospitals to lose an estimated $9B annually because of nonreimbursed litigation costs.
A majority of BSIs result from bacteria inside hospitals finding its way into patients' bloodstreams, particularly through needleless IV hub-and-port systems. Contamination of the hub-and-port system often occurs when the port hub is exposed to environmental elements during IV changeover, thus resulting in an unsanitary port connection.
The so-called Scrub-the-Hub Protocol (the “Protocol”) establishes an approach to ensure that hubs, ports, and connectors are properly cleaned to eliminate the risk of BSIs. Typically, alcohol- or chlorhexidine-soaked swabs are used to abrasively scrub the components of an IV system for a given period of time to remove viruses, bacteria, yeast, fungi, and other biofilms that can cause BSIs. Because of the ease with which they can be prevented using the Protocol, the Center for Medicare and Medicaid characterizes BSIs as “never events” (i.e., events that should never occur).
Unfortunately, studies question compliance with the Scrub-the-Hub Protocol. In particular, research suggests that IV systems often are not scrubbed for the recommended duration or with the proper amount of friction to remove biofilms. For example, the Protocol recommends cleaning IV ports for at least 15 seconds and some facilities recommend cleaning for 30 seconds, but current estimates reveal that most healthcare professionals clean the IV ports for approximately nine seconds.
Accordingly, there is a need for improved systems and methods to address the above mentioned deficiencies. Embodiments of the present disclosure are directed to these and other considerations.
Briefly described, and according to one embodiment, aspects of the present disclosure generally relate to an apparatus and method for providing a visual indication that a sufficient amount of abrasive scrubbing has occurred for a given period of time to properly sterilize various medical devices and medical equipment including needless intravenous hub-and-port systems. The apparatus may be embodied as a sanitizing swab, which may alternatively be referred to as a “wipe” or a “sanitizing wipe.” The sanitizing swab may comprise a plurality of layers of non-woven material or fabric (e.g., cotton). The sanitizing swab may further comprise an indicating film disposed between a first and second layer of non-woven material, and the indicating film may comprise a polymeric film and a plurality of microencapsulated dyes incorporated into the polymeric film. Further, the plurality of microencapsulated dyes burst upon sufficient uniaxial force being applied thereto and the bursting of the plurality of microencapsulated dyes causes the sanitizing swab to undergo a change in visual state.
In one embodiment, a method for producing a sanitizing swab is provided. The method can include producing, via a spray-drying rotating disk process, a plurality of microencapsulated dyes. Further, the method may include incorporating the plurality of microencapsulated dyes into a polymeric film to generate an indicating film. The method can also include disposing, using a laminating process, the indicating film between a first layer of non-woven material and a second layer of non-woven material.
These and other aspects, features, and benefits of the present disclosure will become apparent from the following detailed written description of the preferred embodiments and aspects taken in conjunction with the following drawings, although variations and modifications thereto may be effected without departing from the spirit and scope of the novel concepts of the disclosure.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate multiple embodiments of the presently disclosed subject matter and, together with the description, serve to explain the principles of the presently disclosed subject matter; and, furthermore, are not intended in any manner to limit the scope of the presently disclosed subject matter. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like elements of an embodiment, and wherein:
Certain embodiments of the disclosed technology provide an apparatus and method for properly cleaning medical equipment according to prescribed guidelines. In particular, certain embodiments provide an apparatus and method for providing a visual indication that a sufficient amount of abrasive scrubbing has occurred for a given period of time to properly sterilize various medical devices and medical equipment including needless intravenous hub-and-port systems.
Although certain embodiments of the disclosure are explained in detail, it is to be understood that other embodiments are contemplated. Accordingly, it is not intended that the disclosure is limited in its scope to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. Other embodiments of the disclosure are capable of being practiced or carried out in various ways. Also, in describing the embodiments, specific terminology will be resorted to for the sake of clarity. It is intended that each term contemplates its broadest meaning as understood by those skilled in the art and includes all technical equivalents which operate in a similar manner to accomplish a similar purpose.
It should also be noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural references unless the context clearly dictates otherwise. References to a composition containing “a” constituent is intended to include other constituents in addition to the one named. Also, in describing the preferred embodiments, terminology will be resorted to for the sake of clarity. It is intended that each term contemplates its broadest meaning as understood by those skilled in the art and includes all technical equivalents which operate in a similar manner to accomplish a similar purpose.
Herein, the use of terms such as “having,” “has,” “including,” or “includes” are open-ended and are intended to have the same meaning as terms such as “comprising” or “comprises” and not preclude the presence of other structure, material, or acts. Similarly, though the use of terms such as “can” or “may” is intended to be open-ended and to reflect that structure, material, or acts are not necessary, the failure to use such terms is not intended to reflect that structure, material, or acts are essential. To the extent that structure, material, or acts are presently considered to be essential, they are identified as such.
It is also to be understood that the mention of one or more method steps does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. Moreover, although the term “step” may be used herein to connote different aspects of methods employed, the term should not be interpreted as implying any particular order among or between various steps herein disclosed unless and except when the order of individual steps is explicitly required.
The components described hereinafter as making up various elements of the disclosure are intended to be illustrative and not restrictive. Many suitable components that would perform the same or similar functions as the components described herein are intended to be embraced within the scope of the disclosure. Such other components not described herein can include, but are not limited to, for example, similar components that are developed after development of the presently disclosed subject matter.
The materials described as making up the various elements of the present invention are intended to be illustrative and not restrictive. Many suitable materials that would perform the same or a similar function as the materials described herein are intended to be embraced within the scope of the present invention. Such other materials not described herein can include, but are not limited to, for example, materials that are developed after the time of the development of the present invention.
Example embodiments of the disclosed technology will now be described with reference to the accompanying figures.
As discussed, intravenous (“IV”) systems commonly are used in healthcare for delivering drugs, blood, and nutrients quickly into the body.
As will be appreciated, proper cleaning of both ports and connectors is imperative to maintain a sterile state. In particular, hospitals and other entities such as the Centers for Disease Control (“CDC”) establish protocols to ensure that the ports and connectors are properly cleaned to reduce the risk of device-related bloodstream infections (“BSIs”) or central-line associated bloodstream infections (“CLABSIs”). The CDC established The CDC established the Hemodialysis Central Venous Catheter Scrub-the-Hub Protocol (the “Scrub-the-Hub Protocol” or the “Protocol”) that mandates that IV ports and connectors be cleaned prior to use. Generally, as shown in
Recent studies, however, question whether medical practitioners follow the sterilization protocols and, in particular, the Scrub-the-Hub Protocol. Specifically, studies show that practitioners do not scrub IV system components for the recommended duration or with the proper amount of friction to properly remove biofilms that promote bacterial growth.
Aspects of the present disclosure relate to chromically indicated sterile wipes (“CISWs”), such as CISW 200 shown in
In some embodiments, a CISW 200 can comprise a pressure and/or friction responsive microencapsulated dye that can be time-activated and that can rupture upon successful use of the CISW 200 according to a prescribed protocol. So, for example, in some embodiments, a CISW 200 can comprise a microencapsulated dye that ruptures after between 5 and 30 seconds of vigorous rubbing, thus resulting in a change of color to the CISW 200′, as shown in
Further, in some embodiments, a CISW 200 can comprise a microencapsulated dye that ruptures when the practitioner scrubs the IV component vigorously or abrasively according to a prescribed protocol. So, for example, in some embodiments, a CISW 200 can comprise a microencapsulated dye that ruptures when a practitioner uses the CISW 200 to scrub an IV component with a predetermined force as low as approximately 0.5 and up to approximately 30 PSI (or between approximately 3,400 and 207,000 Pa) depending on the particular application, protocol, and need. As will be appreciated, 2 PSI is approximately twice the adhesion force of an E. coli bacterium and thus may be adequate to sanitize surfaces, though some protocols or applications may require greater pressure.
As will be understood by one of skill in the art, a microcapsule generally is a capsule having a coating that surrounds particles or droplets. Put differently, a microcapsule is a small sphere with a uniform wall around it and a material inside. According to some embodiments of the present disclosure, a microencapsulated dye is a microcapsule comprising a dye or other antiseptic.
Further, in some embodiments, a CISW 200 can comprise a plurality of microencapsulated dyes, shown in
As will be appreciated, in to a CISW 200 meeting requisite FDA cleanliness and sterilization guidelines, when used in a medical setting, microencapsulated dyes 325 included in a CISW 200 should be nontoxic. For example, in some embodiments, the dyes can be water- or alcohol-based. Further, in some embodiments, in addition to microencapsulated dyes, a CISW 200 may include microcapsules 323 (e.g., pressure-sensitive microcapsules) that encapsulate an antiseptic (e.g., iodine or isopropyl alcohol). As will be appreciated, these iodine- or alcohol-filled microcapsules 323 can further enhance the antiseptic qualities of a CISW 200.
In some embodiments, microencapsulated dyes 325 can be incorporated within a polymeric film 315. As will be appreciated, incorporating the microencapsulated dyes 325 into a polymeric film 315 can help prevent dye from coming into contact with a patient or IV system component. In some embodiments, the polymeric film 315 and incorporated microencapsulated dyes 325 can form an indicating film 330 (alternatively, a reactive square), which can be sandwiched between the first and second substrates 305, 310 to form a CISW 200.
In some embodiments, microencapsulated dyes 325 can be incorporated into a CISW 200 through dispersion. For example, the microencapsulated dyes 325 can be dispersed in an isopropyl alcohol solution that is subsequently absorbed into individual layers of non-woven fibers (e.g., first substrate 305 and second substrate 310). The individual layers (e.g., 305, 310) can then be pressed together to form a CISW 200.
As discussed, in some embodiments, a CISW 200 can comprise an indicating film 330 comprising a polymeric film 315 and incorporated microencapsulated dyes 325. As shown in
As shown in
In some embodiments, a CISW (e.g., CISW 200) may comprise microcapsules containing thermochromic dyes (i.e., leuco dyes) that are incorporated into the non-woven material. As will be understood by one of skill in the art, leuco dyes generally comprise molecules that have two forms, one colorless and the other colored, that change based on temperature. Thus, in some embodiments, heat from a practitioner's hands and/or heat created by rubbing a CISW on an IV component can cause a rise in temperature, which in turn causes a color change, which is reversible. To maintain the reversibility, the leuco dye typically is encapsulated in a protective polymer shell. In some embodiments, thermochromic liquid crystals (“TLCs”) can be substituted for leuco dyes. Typically, the TLCs undergo changes in pitch with temperature change, thus altering the Bragg's reflection of light that emits from the material. Further, in some embodiments, using multiple TLCs in a CISW can increase the range of temperature in which the CISW retains functionality, thereby increasing the range of colors achieved while the CISW is in use.
While certain embodiments of the disclosed technology have been described in connection with what is presently considered to be the most practical and various embodiments, it is to be understood that the disclosed technology is not to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.
This written description uses examples to disclose certain embodiments of the disclosed technology, including the best mode, and also to enable any person of ordinary skill to practice certain embodiments of the disclosed technology, including making and using any devices or systems and performing any incorporated methods. The patentable scope of certain embodiments of the disclosed technology is defined in the claims, and may include other examples that occur to those of ordinary skill. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal language of the claims.
This application claims benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Nos. 61/983,485, filed Apr. 24, 2014, entitled “Chromically indicating sterile wipes (CISW),” which is incorporated herein by reference as if set forth herein in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US15/27238 | 4/23/2015 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 61983485 | Apr 2014 | US |
